Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants

Pfizer20 enrolled

Overview

This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled, evaluator blinded study to assess the skin irritation potential with a range of concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum under occlusive conditions in adult Japanese healthy participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-06700841 creamDRUG

PF-06700841 will be applied topically

White petrolatumDRUG

White petrolatum will be applied topically

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document. * Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. * Participants who have any visible skin condition at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction. * Participants who have psoriasis and/or active AD/eczema/urticaria. * Participants who have a history of AD. * Participants who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site. * History of known or suspected intolerance to any of the ingredients of the investigational products, adhesive tape/plaster, or the test patches.

Locations (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4

Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++)

Time frame: Up to Day 4

Secondary Outcomes

The proportion of participants who have skin irritation grade equal to or greater than two plus (++) on each assessment day (Day 3 and Day 4)

Time frame: Day 3 and Day 4

The number of the maximum skin irritation score reported up to Day 4 by treatment

Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4)

Time frame: Up to Day 4

The percentage of the maximum skin irritation score reported up to Day 4 by treatment

Time frame: Up to Day 4

The number of each skin irritation score reported by treatment on each assessment day

Time frame: Day 3 and Day 4

Data from ClinicalTrials.gov

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